Patients diagnosed with COVID-19 by positive PCR for SARS-COV2 MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Favipiravir
Product Code: Favipiravir
Pharmaceutical Form: Tablet
INN or Proposed INN: FAVIPIRAVIR
CAS Number: 259793-96-9
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Ferrer Internacional, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Adult age: from 18 to 85 years included (at the time of informed consent) of both genders 2.Patients with categories 3 to 5 on the ordinal scale 3.Patients who meet all of the following criteria 1), 2), 3), and 4) at the time of enrollment 1)Patients who tested positive for SARS-COV2 on RT-PCR test from respiratory specimen(s) 2)Patients with new lung lesions on chest images (chest x-ray, CT scan, etc.) 3)Patients with SpO2 =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1.Patients who show increased procalcitonin levels (1 ng/ml or higher) before the start of study drug administration and are suspected to have concurrent bacterial infection 2.Patients who show abnormal NT-pro BNP levels (400 pg/mL or higher) and are suspected to have concurrent congestive heart failure 3.Patients with severe hepatic impairment (>Grade 3: ALT >10 times of upper normal limit) 4.Patients with renal impairment requiring dialysis 5.Patients with disturbed consciousness such as disturbed orientation (except with a nasogastric tube administration) 6.Pregnant or possibly pregnant patients and lactating or nursing female patients 7.Patients (and their partners) who desire to become pregnant during the study period or who cannot abstain from sex or who will not use contraceptives from the start of favipiravir until 14 days after end of administration 8.Male patients whose partner cannot agree to use the contraception method described above (criterion 7) 9.Patients who cannot consent to the use of condoms from the start of favipiravir administration to 14 days after the end of favipiravir administration 10.Patients with hereditary xanthinuria 11.Patients who have previously ever been diagnosed with hypouricemia (< 1 mg/dL) or xanthine urinary calculi 12.Patients with a history of gout or on treatment for gout or hyperuricemia 13.Patients receiving immunosuppressants (tocilizumab and corticosteroids administration is permitted) 14.Other patients judged ineligible by the principal investigator or sub-investigator 15.Known allergy to any study medication and its excipients 16.Patients on the current treatment or who have been treated during last 7 days with remdesivir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of the study is to evaluate the clinical safety and potential efficacy of favipiravir relative to the control arm in patients hospitalized with COVID-19;Secondary Objective: The overall objective of the study is to evaluate the clinical safety and potential efficacy of favipiravir relative to the control arm in patients hospitalized with COVID-19;Primary end point(s): Time to clinical improvement measured as improvement for = two categories on a 7-point ordinal scale (Time frame: up to 28 days): 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 7. Death.;Timepoint(s) of evaluation of this end point: Time frame: up to 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Clinical Severity 1)Ordinal scale: ? Subject clinical status on an ordinal scale at days 3, 5, 8, 11, and 28 ? Mean change in the ranking on an ordinal scale from baseline to days 3, 5, 8, 11 and 28 2)National Early Warning Score (NEWS): ? The time to discharge or to a NEWS of = 2 and maintained for 24 hours, whichever occurs first. ? Change from baseline to days 3, 5, 8, 11 and 28 in NEWS 3)Oxygenation: ? Oxygenation free days in the first 28 days (if the patient is still hospitalized) or up to hospital discharge ? Incidence and duration of new oxygen use during the trial. 4)Mechanical Ventilation: ? Ventilator free days in the first 28 days (if the patient is still hospitalized) or up to hospital discharge. ? Incidence and duration of new mechanical ventilation use during the trial. 5)Hospitalization ? Duration of hospitalization (days). 6)Mortality up to 28 days;Timepoint(s) of evaluation of this end point: Time frame: up to 28 days | — |
Countries
Spain
Contacts
Public ContactRebeca Aldonza Aguayo
Ferrer Internacional, S.A.
Outcome results
None listed